Cleared Traditional

K252893 - ExaStim Stimulation System (EXA-001)

Also marketed or referenced as:
ExaStim® Stimulation System (EXA-011) ReCure® Electrode Pad (PAD-003) ReCure® Electrode Pad (PAD-013)

K252893 is an FDA 510(k) clearance for ExaStim Stimulation System (EXA-001), manufactured by Aneuvo. The device is a Class 2 Physical Medicine device with product code SDO cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K252893 · Aneuvo · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2026
Decision
197d
Days
Class 2
Risk

K252893 is an FDA 510(k) clearance for the ExaStim® Stimulation System (EXA-001). Classified as Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation (product code SDO), Class II - Special Controls.

Submitted by Aneuvo (Los Angeles, US). The FDA issued a Cleared decision on March 27, 2026 after a review of 197 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5851 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Aneuvo devices

FDA 510(k) Submission Details - K252893

510(k) Number K252893 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2025
Decision Date March 27, 2026
Days to Decision 197 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 115d · This submission: 197d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

SDO Device Classification - Class 2, Special Controls

Product Code SDO Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5851
Definition A Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation Is A Device That Can Be Programmed To Apply An Electrical Current Via Electrodes On A Patient's Skin Over The Spine To Improve Muscle Strength And Sensation After Neurological Deficit.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.